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New Annex 16 - deadline for coming in to operation 15th Apr 2016

14 October 2015   (0 Comments)
Posted by: Tamsin Marshall
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EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

 

Annex 16: Certification by a Qualified Person and Batch Release

 

The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified.

 

Subject: New Annex 16 - deadline for coming in to operation 15th Apr 2016

More information found on the below link

 

http://ec.europa.eu/health/files/eudralex/vol-4/v4_an16_201510_en.pdf

 

 


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